When does Annex I require a notified body?
Start with Annex I. Part A covers categories that must use one of the third-party routes in Article 25(2): followed by conformity to type, , or . Those routes involve a .
Part B gives manufacturers more room, but not always a self-assessment route. Article 25(3) allows internal production control only when the machinery or related product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that coverage is missing or only partial, the manufacturer must use , , or .
If the product is not listed in Annex I, Article 25(4) points to internal production control. A may still be useful commercially or technically, but the Regulation route itself is not the reason unless another applicable EU act requires it.
Notification is scope-specific. Confirm the body's listing for Regulation (EU) 2023/1230, the relevant product category, and the selected module before contracting; accreditation, an older Machinery Directive notification, or a general testing capability does not by itself establish authority for the new Regulation route.
The Article 25 routes apply from 20 January 2027. Before that date, determine the applicable Machinery Directive procedure for the product being placed on the market and confirm the body's notification under that legislation; a Regulation notification should not be used to rewrite the legal basis for an earlier placement.
- Annex I Part A includes removable mechanical transmission devices and guards, vehicle servicing lifts, portable cartridge-operated fixing and impact machinery, certain machine-learning safety components, and machinery embedding such systems where they have not been placed independently on the market, in respect only of those systems.
- Annex I Part B includes listed woodworking and meat-processing saws, certain presses, moulding machinery, underground machinery, refuse trucks with compression mechanisms, lifting devices over 3 m fall hazard, protective devices, safety logic units, ROPS, and FOPS.
- Substantial modification can put the person making the modification into the manufacturer role, including the duty to apply the relevant Article 25 route.
When is a needed under the EU Machinery Regulation?
For Regulation (EU) 2023/1230, which applies from 20 January 2027, use Annex I and Article 25. A is required for Annex I Part A products because the available routes are plus conformity to type, , or . For Annex I Part B, internal production control is available only when the product is designed and constructed using category-specific harmonised standards or common specifications that cover all relevant essential health and safety requirements; otherwise a notified-body route is needed.
Can a manufacturer self-assess an Annex I Part B machine?
Yes, but only on the Article 25(3) condition: the machine must be designed and constructed under harmonised standards or common specifications specific to that Annex I Part B category and covering all relevant EHSRs. If the standard set does not cover all relevant EHSRs, or if the manufacturer uses another technical solution for uncovered requirements, use Module B plus C, Module H, or Module G.
Does a take over the manufacturer's responsibility?
No. The manufacturer still owns the risk assessment, technical documentation, conformity route selection, EU declaration of conformity, CE marking, production controls, and change monitoring. The assesses the defined module: design/type under Module B, the quality system under Module H, or the individual unit under Module G.
Article 25 and Annex I determine when a notified body is required; Articles 52 and 54 establish the pre-20 January 2027 transition and application date.
Commission sector page identifying Machinery Regulation (EU) 2023/1230 and the official machinery-law context.